A Phase III Study of Lenalidomide, Bortezomib, and Dexamethasone Combination Treatment with or without Peripheral Stem Cell Transplantation in the Initial Management of Multiple Myeloma

Protocol
12-018
Full Title
A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients Up to 65 Years of Age
Phase
III
Disease Status
Newly Diagnosed
Purpose

Autologous stem cell transplantation (ASCT), in which some of a patient’s own blood stem cells are removed before high-dose chemotherapy and then re-infused after chemotherapy to repopulate the blood and bone marrow, is commonly used to treat multiple myeloma, but not all patients can tolerate this intense treatment. In this study, researchers want to see if a combination of drugs is as effective as treatment that includes ASCT in patients with newly diagnosed multiple myeloma, to see if some patients can be spared from high-intensity treatment.

All patients in this study will receive the combination of lenalidomide, bortezomib, and dexamethasone (also called RVD), drugs which are used in the treatment of multiple myeloma, and all patients will have blood stem cells collected for possible use during ASCT. Patients will then be randomly assigned to have ASCT followed by maintenance therapy with lenalidomide, or proceed to a few more cycles of RVD followed by maintenance therapy with lenalidomide, without having ASCT.

Patients without ASCT may be offered this treatment later on if their disease eventually progresses.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have symptomatic multiple myeloma that has not previously been treated with chemotherapy or any other systemic therapy.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must between the ages of 18 and 65.

For more information about this study and to inquire about eligibility, please contact Dr. Hani Hassoun at 212-639-3228.

Disease(s)
Hematology: Multiple Myeloma
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